Quality Engineer

MINIMUM WORK EXPERIENCE:  

3 or more years of engineering experience, ideally within the medical device industry, including roles within product development or Quality engineering. Experience in a disciplined engineering environment.  

PREFERRED EDUCATION:  

A Bachelor's Degree in engineering, typically electrical or mechanical. Master's degree in engineering, an MBA or global equivalent a plus. ASQ Certification also a plus.   

GENERAL SKILLS & COMPETENCIES:  

• Previous experience in product engineering, manufacturing engineering and/or quality 
   engineering within the Medical Device Industry.  
• A working knowledge of LEAN and Six Sigma concepts and tools.   
• Outstanding verbal and written communication skills  
• Excellent presentation and public speaking skills  
• Excellent independent decision making, analysis and problem solving skills  
• Understand and act on financial information that contributes to business profitability  
• Ability to plan and manage successful projects; understand available resources, develop timeline, budget, assign tasks and areas of responsibility  
• Excellent planning and organizational skills and techniques  
• Communicate effectively with senior management  
• Good negotiating skills and ability to effectively manage outsourced relationships  

SPECIFIC KNOWLEDGE & SKILLS:  

•  Strong working knowledge of medical device regulations including 21CFR820, MDD, MDR 
  and other global regulatory requirements and quality system standards including ISO14971, IEC 60601 and other relevant standards.  
•  Demonstrated success in the implementation of problem solving methods and tools  
•  Understanding of the effective implementation of the entire risk process, including the 
  identification and implementation of appropriate controls in product development and/or operations.  
•  Experience in product verification/validation, process validation and test system development and implementation. Experience in the development and implementation of processes and testing meant to satisfy quality and regulatory standards in the medical device industry, as well as drive product and process quality. 
• Experience in developing appropriate trending related to operational and product quality. Previous success in driving improvement through root cause analysis and CAPA projects.  
• Strong understanding of best practices related to supplier quality and supplier development 
• General knowledge of regulatory requirements.